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FDA Plan Summary

The Agency plan for PDUFA III is a composite of the plans developed by CDER, CBER, ORA, and OC components. Tables 1-7 on pages 32 and 33 summarize the overall FDA plan. The discussion below summarizes information in each of these tables.

Table 1 (page 32) shows the $975 million set aside over five years to maintain and support the additional staff hired by the end of PDUFA II (referred to as the PDUFA II Additive Base) discussed in Assumption 5. It also shows the total fee revenues projected annually, the reserve set aside for application shortfalls, and the amounts still available for enhancements after the PDUFA II Additive Base funds have been subtracted from the total estimated fees available--a total of about $271 million over the five years.

Table 2 (page 32) shows the allocation of $279 million over five years, by component, planned to meet PDUFA III goals. The yearly amounts and totals for CDER, CBER, ORA, and OC on the first four lines are from their individual plans. The next three lines show the amounts for: (1) information technology, (2) rent, and (3) central accounts. These are necessary to meet PDUFA III goals and to accommodate the additional staff hired by the centers. The total line allocates all the PDUFA funds, above the PDUFA II Additive Base, that FDA expects to spend through FY 2007.

Table 3 (page 32) shows the allocation of this $279 million by PDUFA III goal category. About $129 million (46% of the increases) will be spent for enhanced training and staffing to meet the goals. About $71 million (25% of the increases) is planned for risk management activities. About $33 million (12% of the increases ) is planned for IT/electronic submission enhancements. About 23 million (8% of the increases) is planned for implementing the pilot program for continuous marketing applications. The remaining $23 million (8% of the increase) is planned for enhancements in the remaining 4 goal areas-efficacy supplement resubmissions, first cycle reviews, expert outside consultants, and performance management.

A summary of the additional staff years planned each year, over and above the PDUFA II base levels shown on page 8, are shown below.

PDUFA III Program Staff Year Changes from PDUFA II Additive Base

Organization

2003
Estimate

2004
Estimate

2005
Estimate

2006
Estimate

2007
Estimate

CDER

+60

+135

+218

+270

+293

CBER

+23

+29

+44

+54

+59

OC

+21

+21

+23

+23

+24

Total

+104

+185

+285

+347

+376

Table 4 (page 33) shows the difference between the projected fee revenues and expenditures each year and the estimated PDUFA carryover balances at the beginning and end of each year. In FY 2003, FDA will spend about $2.9 million less than it expects to collect and in FY 2004 about $4.5 million more. FDA can do this because FY 2003 began with about $22.7 million in PDUFA carryover funds. The plan shows that these carryover balances will be spent down to about $14 million in the last year of the program. However, FDA's assumptions about application fee collections reflected in Table 1 may prove too pessimistic, and cause these carry over balances to be higher than the plan shows.

Tables 5 and 6 (page 33) summarize the allocation of the $1,254,248,000 total fee revenue that FDA plans to spend over the five years of PDUFA III (PDUFA II additive base plus PDUFA III increases) by component (Table 5) and by expense category (Table 6). The last column in both tables shows the percent of total PDUFA funds planned over the next five years. By component, CDER will be allocated 58 percent, CBER 11 percent, ORA 2 percent, overhead 8 percent, information technology 11 percent, central accounts 5 percent, and rental payments to GSA 4 percent. By other expense categories, 64 percent of the total PDUFA III revenues will be dedicated to pay and benefits for staff (same as in the original plan), 15 percent for operating costs, 11 percent for IT.

Table 7 (page 33) summarizes the total PDUFA staff years planned each year, showing the number of staff years paid from the salary and expense appropriations, the number of staff years paid from fees and considered the PDUFA II additive base, and the number of staff years added over the course of PDUFA III under this plan.